Kornimate/medical-research-clean huggingface dataset:
co2 laser phototherapy for management of mature burn scars

Conditions: Burn Scar

Summary: evaluate mature burn scars before and after treatment with co2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

laser phototherapy has gained growing acceptance and popularity for management of burn scars. the most commonly used laser is the carbon dioxide (co2) laser. at this institution, the investigator has used co2 for management of burn scars since 2012. while the existing literature and the investigator's anecdotal experience thus far has been positive overall, there is no conclusive evidence to support that co2 does indeed improve the quality of mature burn scars the primary objective of this study is to evaluate mature burn scars before and after treatment with co2 for patients age 3-21 while comparing the treated areas to an untreated control area in the same patient.

Eligibility criteria:
inclusion criteria: * age 3 to 21 * patients with mature burn scars that are at least two years old from burn injury and that have not previously undergone co2 laser therapy for scar revision. * scars in all body areas with the exception of face, genitals or hands will be considered eligible for the study * entry into this study is open to pediatric patients of both genders. * entry into this study is open to pediatric patients of all ethnic backgrounds. * entry into this study is open to females of childbearing potential with a negative urine or serum pregnancy test exclusion criteria: * patients with scars less than 2 years old * patients with contraindications to laser treatment (i.e.: active acne infections/ treatment with isotretinoin, active zoster infection) * patients receiving other forms of scar revision therapy such as other laser types, steroid injections, or surgical excisions.
ctdna-guided surveillance for stage iii crc, a randomized intervention trial

Conditions: Colorectal Cancer; Colo-rectal Cancer; ctDNA; Gastro-Intestinal Disorder; Colorectal Neoplasms; Gastrointestinal Cancer; Gastrointestinal Neoplasms; Digestive System Disease; Digestive System Neoplasm; Colonic Diseases; Colonic Neoplasms; Colonic Cancer; Rectal Diseases; Rectal Neoplasms; Rectal Cancer

Summary: improve-it2 is a randomized multicenter trial comparing the outcomes of ctdna guided post-operative surveillance and standard-of-care ct-scan surveillance. the hypothesis of this study is that ctdna guided post-operative surveillance combining ctdna and radiological assessments could result in earlier detection of recurrent disease and identify more patients eligible for curative treatment.


Eligibility criteria:
inclusion criteria: * colon or rectal cancer, tumor stage iii (pt1-4n1-2,cm0) or stage ii high-risk (pt4n0,cm0 and pt3n0, cm0 with risk factors) * have received curative intend resection and be candidates for adjuvant chemotherapy exclusion criteria: * not treated with adjuvant chemotherapy * synchronous colorectal and non-colorectal cancer diagnosed per-operative (except skin cancer other than melanoma) * other cancers (excluding colorectal cancer or skin cancer other than melanoma) within 3 years from screening * patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits) and/or otherwise considered by the investigator to be unlikely to complete the study.
a study to evaluate aln-htt02 in adult patients with huntington's disease

Conditions: Huntington's Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (pd) and pharmacokinetics (pk) of a single dose of aln-htt02.


Eligibility criteria:
inclusion criteria * has stage 2 or early stage 3 huntington's disease (hd), per the huntington's disease integrated staging system (hd-iss) exclusion criteria * has significant structural or degenerative neurologic disease other than huntington's disease (hd) at screening * has primary or secondary immune compromise at screening due to infections, medical conditions, or chronic therapies * has alanine aminotransferase or aspartate aminotransferase \>2× upper limit of normal (uln) * has an estimated glomerular filtration rate (egfr) of \<45 ml/min/1.73m\^2 at screening * has received an investigational agent within the last 1 year or 5 half-lives (if known) note: other protocol defined inclusion / exclusion criteria apply

Keywords: sirna aln-htt02 intrathecal hd-iss stage 2 hd-iss early stage 3 neurodegenerative disorder
noninvasive ventilation for chronic heart failure

Conditions: Chronic Stable Heart Failure

Summary: the effects of home noninvasive ventilation on renin-angiotensin system (ras), kallikrein-kinin system (kks) and cardiac remodeling in patients with chronic stable heart failure have not been reported. this project aims to clarify the efficacy and safety of home non-invasive ventilation in patients with chronic heart failure complicated with sleep-disordered breathing. first, patients with chronic stable heart failure were selected and monitored by polysomnography. patients with sleep apnea hypopnea syndrome (sahs, ahi≥15) were randomly divided into two groups: the treatment group was treated with non-invasive ventilator at home (≥5h/ night); the control group was only given routine treatment. after 6 months of follow-up, the effects of sleep disordered breathing and noninvasive ventilation on ras, kks, cardiac remodeling and function and cardiovascular adverse events in patients with chronic heart failure were evaluated. the results are helpful to further reveal the role of sleep disordered breathing in the occurrence and development of chronic heart failure, and provide a new diagnosis and treatment strategy for chronic heart failure.


Eligibility criteria:
inclusion criteria: * 1) the history of chronic stable heart failure exceeds 3 months; 2) 18\~75 years old; 3) nyha cardiac function classified as grade ii\~iv; 4) lvef≤40%； 5) nt-probnp≥450pg/ml； 6) all subjects or their guardians must sign the subject consent before entering the trial. exclusion criteria: * 1) patients with the following diseases: valvular heart disease; congenital heart disease; obstruction of left ventricular outflow tract; severe decompensated heart failure; acute coronary syndrome; active myocarditis or pericardial disease; end-stage liver and kidney diseases; malignant tumor; 2) patients with poor sound transmission windows are examined by transthoracic ultrasound.
the effect of satiety gut hormone modulation on appetitive drive after upper gastrointestinal surgery

Conditions: Esophageal Neoplasms; Stomach Neoplasms; Weight Loss; Malnutrition; Pancreatic Neoplasms; Duodenal Neoplasms

Summary: improvements to treatment strategies for patients with cancers of the upper gastrointestinal tract have produced a large population of people who remain free from cancer recurrence in the long term following treatment. surgery is the cornerstone of treatment for patients with these cancers, but while surgical removal of the tumour may offer the best chance of cure, these are major operations associated with specific long term complications. weight loss and poor nutrition are common problems among patients who attain long-term cancer remission and cure after surgery. the mechanisms underlying these problems are not well understood and therefore treatment options are limited. our research has demonstrated increased levels of chemical messengers (gut hormones) released from the gastrointestinal tract after meals in patients who have previously undergone this type of surgery. these chemical messengers play a role in controlling appetite and interest in food, and increased levels after surgery may reduce interest in eating. understanding the role of gut hormones in the control of appetite may allow us to use certain medications to block gut hormones and hence increase appetite, allowing patients to eat more and regain weight, preventing nutritional problems after surgery. in this study, the investigators aim to determine whether exaggerated gut hormone secretion causes reduced appetite and interest in food after surgery. the information gained from this study may help us to develop treatments for patients with weight loss and nutritional problems after surgery.


Eligibility criteria:
inclusion criteria: 1. surgical procedure: two-stage, three-stage or transhiatal esophagectomy with gastric conduit reconstruction and pyloroplasty, total gastrectomy with roux-en-y reconstruction, pancreaticoduodenectomy, or matched healthy unoperated control subjects 2. disease-free at least one year post-resection exclusion criteria: 1. pregnancy, breastfeeding 2. significant and persistent chemoradiotherapy and/or surgical complication 3. other previous upper gastrointestinal surgery 4. unwell or unable to eat 5. other disease or medications which may affect satiety gut hormone responses 6. active and significant psychiatric illness including substance misuse 7. cognitive or communication issues or any factors affecting capacity to consent to participation 8. history of significant food allergy, certain dietary restrictions 9. confirmed or suspected residual or recurrent disease after surgery, second primary malignancy 10. requiring adjuvant chemotherapy 11. contraindication to octreotide administration 12. history of eating disorder

Keywords: esophagectomy gastrectomy octreotide somatostatin appetite hunger glucagon-like peptide 1 peptide yy reinforcement reward psychological phenomena and processes gastrointestinal agents nutritional status pancreaticoduodenectomy whipple procedure
community health worker and mhealth to improve viral suppression

Conditions: HIV/AIDS

Summary: the overall goal of this study is to evaluate the effects of the champs intervention for people living with hiv (plwh) in a randomized controlled trial. the proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a combined community health worker (chw) and smartphone intervention linked to a smart pill box for antiretroviral (art) adherence in plwh in the united states (us). guided by a rigorous theoretical model of supportive accountability and building on preliminary work, this intervention has the potential to enable plwh to self-manage their art regimens while chw monitor their art adherence in real-time ultimately leading to viral suppression and art adherence.

persons living with hiv (plwh) now achieve a near-normal life expectancy due to antiretroviral therapy (art) which has transformed hiv from a terminal diagnosis to a manageable chronic condition. despite widespread availability of art in the united states (us), many of the country's approximate 1.1 million plwh are not fully benefitting from art due to poor adherence. these suboptimal hiv health outcomes occur at a time when clinicians have limited time and the us healthcare system remains fragmented, further exacerbating the challenges inherent in the lives of underserved, marginalized groups, such as plwh. therefore, the development and evaluation of interventions using a cadre of community health workers (chw) holds promise for addressing these challenges in the us. this study addresses limitations in current research on chw interventions to improve viral suppression and art adherence. the investigators propose to build on strong preliminary data to strengthen a community health worker (chw) intervention using an existing mhealth approach, and provide further information regarding the successful wide-scale implementation of this combination intervention.

Eligibility criteria:
inclusion criteria: * be able to communicate and read in english or spanish * willing to participate in any assigned arm of the intervention * diagnosed with hiv ≥6 months ago * have an hiv-1 rna level \>200 copies/ml, or have at least one "no-show" visit in the past 12 months, or report being virally unsuppressed in the past 12 months * have art adherence \<80%, as measured through single-item self-rating adherence scale (srsi) * own a smartphone exclusion criteria: * reside in a nursing home, prison, and/or receiving in-patient psychiatric care at time of enrollment * terminal illness with life expectancy \<6 months * planning to move out of the area in the next 12 months

Keywords: art plwh
alteration of myocardial deformations in diabetes: relationship to micro-angiopathy

Conditions: Diabetes Mellitus, Type 1

Summary: despite careful monitoring of patients with diabetes, it is so far difficult to predict the occurrence of cardiac events in the evolution. as shown by various studies conducted in patients with diabetes, cardiac involvement can be detected by abnormalities of diastolic or systolic functions using non-invasive investigations such as echocardiography. for 4 years, the evaluation technique of myocardial deformations by two-dimensional speckle tracking strain by echocardiography is the subject of high hopes in the earlier detection of still asymptomatic cardiomyopathies. in the present study, the investigators hypothesized that this technique would improve the detection of myocardial contraction abnormalities in patients with insulin-dependent diabetes mellitus (iddm), and would establish their association with micro-angiopathy, frequently encountered in these patients.

this is a single center case-control study based on routine care, designed to recruit patients with type 1 diabetes mellitus free from any other myocardiopathy. the inclusion will take place over a period of 24 months. no monitoring of patients (no follow-up) is provided under this protocol. the analysis will focus on the combination of the left ventricle myocardial deformations alteration revealed by the echocardiographic 2d strain analysis (\< 18% in absolute value), with the existence of micro-angiopathy in type 1 diabetes mellitus patients with preserved left ventricular ejection fraction ( ≥ 60%). two hundred subjects with type 1 diabetes mellitus will be recruited: 100 subjects with impaired left ventricular myocardial deformation by 2d strain analysis (\< 18% in absolute value), constituting the 'cases' group and 100 subjects without alteration in myocardial deformation (global strain ≥ 18%).

Eligibility criteria:
inclusion criteria: * aged between 18 and 45 years * with diagnosed type 1 diabetes mellitus (with or without complications or peripheric vascular micro-angiopathy) * having a negative myocardial ischemic test (exercise echocardiography) in the previous month inclusion exclusion criteria: * known or suspected coronary artery disease * atrial fibrillation * hypertension * moderate to severe valvular disease * sequelae of myocardial infarction * secondary or primary cardiomyopathy * myocardial conduction abnormalities * pregnancy or breastfeeding.
a study for the participants with metastatic hormone sensitive prostate cancer (mhspc) treated with androgen deprivation therapy (adt) plus apalutamide or enzalutamide

Conditions: Metastatic Hormone-sensitive Prostate Cancer

Summary: the purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (adt) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mhspc).


Eligibility criteria:
inclusion criteria: * must have a histologically or cytologically-confirmed diagnosis of adenocarcinoma of the prostate * must have documented metastatic hormone-sensitive prostate cancer (mhspc) * must have agreed with the treating physician the initiation of either apalutamide or enzalutamide (plus androgen deprivation therapy \[adt\]) treatment, per the treating physician's decision, prior to enrollment into the study * must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/ informed consent form (icf) allowing data collection and source data verification in accordance with local requirements * must have baseline prostate-specific antigen (psa) captured within 30 days prior to the first administration of apalutamide or enzalutamide * must agree to complete patient-reported outcomes (pros) during the study, including the baseline ones collected before the first administration of apalutamide or enzalutamide exclusion criteria: * has already received or is currently receiving either apalutamide or enzalutamide, or any other novel hormonal treatments (including but not limited to abiraterone acetate and darolutamide) * is currently receiving an active treatment for prostate cancer as part of an interventional study * has a progression under adt treatment (and thus became castrate-resistant) prior to start of apalutamide or enzalutamide treatment * has received adt treatment for mhspc for more than 2 months prior to apalutamide or enzalutamide treatment initiation or adt treatment was administered for earlier disease stages within the last 12 months prior to apalutamide or enzalutamide treatment initiation * has received prior docetaxel for the treatment of mhspc * participants is not treated in line with current summary of product characteristics for apalutamide or enzalutamide
positron emission mammography and standard mammography in women at high risk of breast cancer

Conditions: Breast Cancer

Summary: rationale: screening tests may help doctors find cancer cells early and plan better treatment for breast cancer. it is not yet known whether positron emission mammography is more effective than standard mammography in finding breast tumors. purpose: this phase iii trial is studying positron emission mammography to see how well it works compared with standard mammography in women undergoing screening mammogram at boston medical center.

objectives: * to install the breast positron emission mammography system and to test and ensure its compliance with all regulatory agencies including the american college of radiology and the food and drug administration. * to measure and compare the number of call-backs for positron emission mammography (pem) imaging and conventional mammography. * to measure and compare patient satisfaction for both conventional mammography and positron emission mammography in terms of comfort and pain. outline: patients undergo a conventional two-view mammogram and positron emission mammography (pem). immediately following treatment, patients complete a questionnaire on their satisfaction with the standard mammogram and the positron emission mammography. after completion of study treatment, patients are followed annually.

Eligibility criteria:
inclusion criteria: disease characteristics: * scheduled to undergo screening mammogram at one of the boston medical center-affiliated primary care clinics and meets 1 of the following criteria: * dense breast tissue * at high-risk for breast cancer patient characteristics: * has 1 of the following racial or ethnic backgrounds based on the patient's country of birth or the mother and father's country of birth: * hispanic * haitian creole * african american * caucasian prior concurrent therapy: * none specified exclusion criteria: * no history of breast cancer, palpable breast mass, abnormal nipple discharge, or other focal complaints warranting diagnostic mammogram

Keywords: breast cancer
comparison of oral anticoagulants for extended venous thromboembolism

Conditions: Venous Thromboembolism

Summary: comparison of oral anticoagulants (warfarin, apixaban and rivaroxaban) for extended venous thromboembolism.

determine if apixaban is superior to warfarin in the reduction of clinically relevant bleeding. determine if rivaroxaban is superior to warfarin in the reduction of clinically relevant bleeding. determine if apixaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. determine if rivaroxaban is non-inferior to warfarin in the prevention of recurrent venous thromboembolism. an exploratory comparison of apixaban versus rivaroxaban for the prevention of clinically relevant bleeding and recurrent venous thromboembolism (vtes) as a secondary objective.

Eligibility criteria:
3.1 inclusion criteria to be eligible for this trial, patients must meet all of the following criteria: * have confirmed acute, symptomatic, first lower extremity proximal dvt and/or pe that is not associated with a transient risk factor. * have completed an initial treatment course of oral anticoagulant therapy for 3-12 months and have a recommendation from their provider to continue anticoagulation indefinitely. * have the capacity to understand and sign an informed consent form. * be 18 years of age and older. * under the direct care of a healthcare provider for treatment of vte for the length of time in the study. 3.2 exclusion criteria if a patient meets any of the following criteria, he or she may not be enrolled in the study: * creatinine clearance (crcl) \< 30 ml/min as determined by cockcroft-gault formula documented within 3 months from date of consent * significant liver disease (child-pugh b or c) * concomitant use of medications that are strong p-glycoprotein or cyp3a4 inducers/inhibitors * another indication for chronic therapeutic-dose anticoagulation, such as atrial fibrillation (i.e., rivaroxaban, 10 mg daily, or apixaban, 2.5 mg twice daily, would not be appropriate therapy) * a clinical indication for a specific anticoagulant regimen (e.g., warfarin with a target inr of 2-3 is recommended for patients with 'triple-positive' antiphospholipid syndrome). * life expectancy \< 3 months * currently pregnant or breast feeding * unable / unwilling to pay for one (or more) of the treatment options * active cancer defined as: diagnosed with cancer within the past 6 months; or recurrent, regionally advanced or metastatic disease; currently receiving treatment or have received any treatment for cancer during the 6 months prior to randomization; or a hematologic malignancy not in complete remission • unwilling / unlikely to agree to follow up
the possible efficacy and safety of l-carnitine and biotin as adjunctive therapies in children with moderate persistent asthma

Conditions: Moderate Persistent Asthma

Summary: the possible efficacy and safety of l-carnitine and biotin as adjunctive therapies in children with moderate persistent asthma


Eligibility criteria:
inclusion criteria: * children with moderate persistent asthma * age range of 8-\< 18 years old * both sex exclusion criteria: * children with any pulmonary or chronic systemic diseases other than asthma (cystic fibrosis, bronchiectasis, tuberculosis, diabetes mellitus, and liver disease). * children with immunodeficiency. * children with thyroid disorder. * children with recent infection (especially pneumonia), surgery, anesthesia. * children having clinical evidence of any heart renal and hepatic diseases. * children having cystic fibrosis or congenital respiratory disease. * children having chronic diarrhea and mal-absorption. * children having clinical evidence of malnutrition. * children on medications that could interfere with l-carnitine level including antibiotics use. (particularly ampicillins) and anti- convulsing particularly valoproic acid.